Date: February 12, 2025
FDA Approves Adcetris Overview
The FDA has approved a new combination therapy for adults with relapsed or refractory Large B-cell Lymphoma (LBCL) on February 11, 2025. This therapy combines Brentuximab Vedotin (Adcetris), Lenalidomide, and Rituximab and is intended for patients who have undergone at least two prior systemic therapies and are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
Key Details of the Approval:
- Target Population: For adults with LBCL, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL).
- Efficacy Data from ECHELON-3 Trial:
- Overall Survival (OS): Median OS of 13.8 months for the treatment group vs. 8.5 months for the placebo group (HR 0.63, p=0.0085).
- Progression-Free Survival (PFS): Median PFS was 4.2 months vs. 2.6 months (HR 0.53, p < 0.0001).
- Objective Response Rate (ORR): 64.3% in the treatment arm compared to 41.5% in the placebo arm.
- Safety Profile: Common adverse reactions include fatigue, diarrhea, peripheral neuropathy, rash, pneumonia, and COVID-19 infection. Notable lab abnormalities were decreases in neutrophils, lymphocytes, platelets, and hemoglobin. Peripheral neuropathy occurred in 27% of patients, leading to dose adjustments or discontinuation in some cases.
- Dosage: The recommended dose for Brentuximab Vedotin is 1.2 mg/kg up to a maximum of 120 mg, administered every three weeks in combination with Lenalidomide and Rituximab, until disease progression or unacceptable toxicity.
This approval provides an additional treatment option for LBCL patients. For more detailed information, the full prescribing guide will be available on Drugs@FDA.
Clinical Practice Implications:
This combination therapy offers a new treatment option for LBCL, particularly for those who cannot undergo more aggressive therapies. It may improve survival outcomes for these patients.
Healthcare providers are encouraged to consider this therapy in their treatment plans. Further research could refine treatment strategies.
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Please note: This post is for informational purposes only and should not replace professional medical advice. Always consult with healthcare professionals before making treatment decisions.
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